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Elemental Impurity Analysis in Pharmaceuticals

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Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients.

Guidance document Q3D reached step four in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the EU, Switzerland, Japan, the US and Canada.